instituitionalising effective regulation of bio-fertilizer ... · • bio-pesticide and...

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he Federal government of Nigeria established National Agency for Food and Drug Administra- tion and Control (NAFDAC)by Decree 15 of 1993 as amended by Decree 19 of 1999 and now the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria 2004 with the mandate to regulate and control the manu- facture, importation, exportation, distribution, advertise- ment, sale and use of food, drugs, cosmetics, chemicals, detergents, medical devices and packaged water (known as Regulated Products). NAFDAC Headquarters in the Federal Capital Terri- tory, ABUJA, Nigeria. The mission is to safeguard public health by ensuring that only the right quality food, drugs and other regulated products are manufactured, imported, exported, distrib- uted, advertised, sold and used in Nigeria. Our core values are to: Ensure availability of efficacious, safe and good quality NAFDAC regulated products. Maintain reference laboratories of international standard. Promote an effective and efficient well motivated and disciplined workforce. In line with the mandate and vision of the Agency, the management obtained approval to restructure the Agency into Thirteen (13) from the previous Nine (9) Directorates to improve efficiency which brought about the establishment of Veterinary Medicine and Allied Product Directorate. In carrying out our mandate, the Agency shall have the following functions amongst others: 1. Conduct appropriate test and ensure compliance with standard specification. 2. Compile standard specifications and guidelines for production, importation, exportation, distribution and sale of regulated products. 3. Undertake appropriate investigation into the produc- tion premises and raw materials for regulated products. 4. Pronounce on the quality and safety of Regulated Prod- ucts after appropriate analysis. 5. Control exportation and issue quality certification of Regulated Products intended for export purposes. 6. Undertake registration of regulated products. 7. Monitor advertisement of regulated products. 8. Establish and maintain relevant laboratories or other institutions in strategic areas of Nigeria. 9. Undertake and co-ordinate research programmes on the Storage, Adulteration Distribution and Rational use of regulated products. Authors: Mudashir . I., Tarus D., Mensah A., Masso C., Watiti J., F. Nang’ayo T Issue No. 5 July 2015 Source: A retailer in an agrochemical outlet in the Northern Region of Nigeria Instituitionalising Effective Regulation of Bio-fertilizer and Bio-pesticide in Nigeria

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Page 1: Instituitionalising Effective Regulation of Bio-fertilizer ... · • Bio-pesticide and Bio-fertilizer Regulations final gazette by the ministry of Justice. • Sustain capacity building

he Federal government of Nigeria established National Agency for Food and Drug Administra-tion and Control (NAFDAC)by Decree 15 of

1993 as amended by Decree 19 of 1999 and now the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria 2004 with the mandate to regulate and control the manu-facture, importation, exportation, distribution, advertise-ment, sale and use of food, drugs, cosmetics, chemicals, detergents, medical devices and packaged water (known as Regulated Products). NAFDAC Headquarters in the Federal Capital Terri-tory, ABUJA, Nigeria.

The mission is to safeguard public health by ensuring that only the right quality food, drugs and other regulated products are manufactured, imported, exported, distrib-uted, advertised, sold and used in Nigeria. Our core values are to:• Ensure availability of efficacious, safe and good

quality NAFDAC regulated products.• Maintain reference laboratories of international

standard.• Promote an effective and efficient well motivated

and disciplined workforce.

In line with the mandate and vision of the Agency, the management obtained approval to restructure the Agency into Thirteen (13) from the previous Nine (9) Directorates to improve efficiency which brought about the establishment of Veterinary Medicine and Allied Product Directorate.In carrying out our mandate, the Agency shall have the following functions amongst others:1. Conduct appropriate test and ensure compliance with

standard specification.

2. Compile standard specifications and guidelines for production, importation, exportation, distribution and sale of regulated products.

3. Undertake appropriate investigation into the produc-tion premises and raw materials for regulated products.

4. Pronounce on the quality and safety of Regulated Prod-ucts after appropriate analysis.

5. Control exportation and issue quality certification of Regulated Products intended for export purposes.

6. Undertake registration of regulated products.7. Monitor advertisement of regulated products.8. Establish and maintain relevant laboratories or other

institutions in strategic areas of Nigeria.9. Undertake and co-ordinate research programmes on the

Storage, Adulteration Distribution and Rational use of regulated products.

Authors: Mudashir . I., Tarus D., Mensah A., Masso C., Watiti J., F. Nang’ayo

T

Issue No. 5 July 2015

Source: A retailer in an agrochemical outletin the Northern Region of Nigeria

Instituitionalising Effective Regulation of Bio-fertilizerand Bio-pesticide in Nigeria

Page 2: Instituitionalising Effective Regulation of Bio-fertilizer ... · • Bio-pesticide and Bio-fertilizer Regulations final gazette by the ministry of Justice. • Sustain capacity building

The establishment of the Veterinary Medicine and Allied Products Directorate is to:-➢ Provide science based advice on the quality, safety

and efficacy of agricultural inputs.➢ Develop and promote standards, regulations and

guidelines in consultation with other Government Agencies and Stakeholders on pesticides and agricul-tural inputs.

➢ Monitor the distribution, sale and use of pesticides and agricultural inputs.

➢ Supervise the conduct of field trials for pesticides and agricultural inputs and evaluate the data.

➢ Inspect and monitor production premises for pesti-cides and agricultural inputs

The essence of regulation and control is to ensure that only quality regulated products that are safe, efficacious and wholesome reach the market and ultimately the consuming public. This is achieved through various processes of the Agency including product registration, inspection of production facilities, laboratory evaluation, post marketing surveillance and enforcement activities. Source: A retailer in an agrochemical outlet in the North-ern Region of Nigeria

In 2012, AATF invited NAFDAC along with representa-tives from other Regulatory authority in Africa to a Bio-pesticide registration guidance document draft review Workshop and in line with international practice, a com-mittee was set up to review the pesticide registration regulation.

Recommendation of the said committee was to review the current pesticide regulation to capture Bio-pesticide and Bio-fertilizer.

In 2012, facilitation came from COMPRO II Project on the establishment and institutionalization of Regulatory framework on Bio-pesticide and Bio-fertilizer in NAFDAC.A fallout of which brought about thedevelop-ment of the under listed draft regulations:-

• Bio-pesticide Registration Regulation• Bio-pesticide Labeling Regulation• Bio-pesticide Advertisement Regulation• Bio-fertilizer Registration Regulation• Bio-fertilizer Labeling Regulation• Bio-fertilizer Advertisement Regulation• Fertilizer Registration Regulation• Fertilizer Labeling Regulation• Fertilizer Advertisement Regulation

The process of establishment and Institutionalization of regu-latory framework will follow a process as stated below:-Constitution of Committee to draft document→Review by Standard Regulation Committee→Review by Stakeholders→ Review by Legal → Governing council for ratification→ Ministry of Justice togazette.

CURRENT EFFORTS• Grassroots sensitization and advocacy visits to decision

makers and opinion leaders as well as organize consulta-tive meetings and workshops with different stakeholders across Nigeria.

• Develop and review documents on Quality control for Bio-pesticide and Bio-fertilizer.

• Development and Verification of Standard Operating Procedure (SOP) for Quality Control of (Rhizobium, Trichoderma, Arbuscular Mycorrhyzal, Pseudomonas, Azotobacter, Baccillus spp and Azospirilium) Bio-fertilizer.

• Development of draft regulations for Bio-pesticide and Bio-fertilizer for Registration, Labeling and Advertise-ment.

• Development and implementation of registration guide-lines for indigenous andforeign Bio-pesticide and Bio-fertilizer.

• Training of inspectors and technicians from NAFDAC and IAR on Bio-pesticide and Bio-fertilizer inspection and sampling.

• Identify independent laboratories collaboration in other geopolitical zones of the country.

WAY FORWARD• Conduct awareness campaigns for stakeholders and

dealers of Bio-pesticide and Bio-fertilizer on the new regulations and guidelines to ensure only registered, qual-ity and safe products are in the market

• Sustain awareness campaign for the general public on the safe handling, storage and the implication of buying unregistered Bio-pesticide and Bio-fertilizer across the six geo-political zones of the country.

• Bio-pesticide and Bio-fertilizer Regulations final gazette by the ministry of Justice.

• Sustain capacity building for inspectors and technicians on the handling and sampling of Bio-pesticide and Bio-fertilizer.

• Establishment of a designated laboratory for quality control of Bio-pesticide and Bio-fertilizer in NAFDAC.